Sanitary products are widely used in various formats for personal hygiene and medical necessity, and include sanitary napkins, diapers, incontinence guards, wound dressings and the like. By their use, a local tissue environment is produced which promotes growth of microbial pathogens, local infections, irritation, rashes, and related problems.
In addition, disposal of used sanitary products is a major environmental and health care concern. The volume of material and the type of material present in the used sanitary product, due to its absorbent character and purpose of collecting body fluids and waste materials, provides a biological and environmental hazard in disposal of used sanitary products. There is a great need for improvements in biodegradation of used sanitary products—degradation of both the product itself and the waste product it contains.
The claimed invention uses a bacterium that is probiotic and heterotrophic to resolve both of the above problems (i.e., to inhibit microbial infections associated with use of sanitary products, and to promote biodegradation of the sanitary product after use).
Probiotic microorganisms are those which confer a benefit when grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotic organisms include bacteria and bacteriophages which possess the ability to grow within the gastrointestinal tract, at least temporarily, to displace or destroy pathogenic organisms, as well as providing other benefits to the host. See e.g., Salminen et al, 1996. Antonie Van Leeuwenhoek 70: 347-358; Elmer et al, 1996. JAMA 275: 870-876; Rafter, 1995. Scand. J. Gastroenterol. 30: 497-502; Perdigon et al, 1995. J. Dairy Sci. 78: 1597-1606; Gandi, Townsend Lett. Doctors & Patients, pp. 108-110, Jan. 1994; Lidbeck et al, 1992. Eur. J Cancer Prev. 1: 341-353.
The majority of previous studies on probiosis have been observational rather than mechanistic in nature, and thus the processes responsible for many probiotic phenomena have yet to be quantitatively elucidated. Some probiotics are members of the normal colonic microflora and are not viewed as being overtly pathogenic. However, these organisms have occasionally caused infections (e.g., bacteremia) in individuals who are, for example, immunocompromised. See e.g., Sussman, J. et al., 1986. Rev Infect. Dis. 8: 771-776; Hata, D. et al., 1988. Pediatr. Infect. Dis. 7: 669-671.
For example, the probiotic bacteria found in sour milk, has been utilized since ancient times (i.e., long-before the discovery of bacteria) as a therapeutic treatment for dysentery and related gastrointestinal diseases. More recently, probiotic preparations were systematically evaluated for their effect on health and longevity in the early-1900's (see e.g., Metchinikoff, E., Prolongation of Life, Willaim Heinermann, London 1910), although their utilization has been markedly limited since the advent of antibiotics in the 1950's to treat pathological microbes. See e.g., Winberg, et al, 1993. Pediatr. Nephrol. 7: 509-514; Malin et al, Ann. Nutr. Metab. 40: 137-145; and U.S. Pat. No. 5,176,911. Similarly, lactic acid-producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been utilized as food additives and there have been some claims that they provide nutritional and/or therapeutic value. See e.g., Gorbach, 1990. Ann. Med. 22: 37-41; Reid et al, 1990. Clin. Microbiol. Rev. 3: 335-344.
The nutritional use of probiotic bacteria, especially Lactobacillus and Biffidobacterium strains, that colonize the gut has been previously disclosed (Winberg, et al., Pediatr. Nephrol. 7: 509-514, 1993; Malin, et al., Ann. Nutr. Metab. 40:137-145, 1996; and U.S. Pat. No. 4,176,911). Lactic acid producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach, Ann. Med. 22: 37-41, 1990; Reid, et al., Clin. Microbiol. Rev., 3: 335-344, 1990). Heterotrophic bacteria play an important role in the biodegradation of animal waste and many natural and synthetic polymers. Bacterial strains including: Bacillus, Pseudomonas, Arthrobacter, Achromobacter, Micrococcus and Rhodococcus have been shown to participate in the breakdown of waste products, cellulose materials, petroleum hydrocarbons and their associated products, such as plastics, synthetic rubbers and other synthetic materials.
Bacillus coagulans is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (Bergey's Manual off Systemic Bacteriology, Vol. 2, Sneath, P. H. A., et al., eds., Williams & Wilkins, Baltimore, Md., 1986). Purified B. coagulans strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336); amylase (U.S. Pat. No. 4,980,180); lactase (U.S. Pat. No. 4,323,651); and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800). B. coagulans has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of B. coagulans (referred to as L. sporogenes; Sakaguti & Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and B. natto to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477).
Use of a sanitary product produces frequent dermal mucoidal irritations and/or infections associated with the use of the product. Diaper rash is a common issue in both adults and infants. Rashes can become more serious irritations when opportunistic pathogens introduced into the sanitary product germinate and cause infections on these irritated sites. In addition, vulva-vaginal infections are common with the use of napkins and tampons and are typically caused by Candida or Gardnerella species (e.g., Candida albicans and C. tropicalis). Toxic Shock Syndrome and other dermal infections caused by Staphylococcal bacteria (e.g., Staphylococcus aureus and S. epidermidis are also common). Other pathogens which can cause infection after brief periods of dermal irritation and/or use of sanitary products include Trichophyton species (e.g., T. mentagrophytes).
In addition, disposable diapers and other sanitary products present environmental problems in their disposal. Sanitary landfills are overused and accumulate excessive amounts of disposed products. Sanitary products such as diapers, sanitary napkins and tampons biodegrade slowly and occupy considerable space due to the bulk of these products, particularly when containing body excrements or fluids which expand due to their absorbent polymer content.